DETAILED ACTION
This Office action is responsive to communications filed on 04/02/2026. Claims 19-20, 22, 24-26 are canceled. Claim 23 is withdrawn. Presently, Claims 1-18, 21, & 23 remain pending and are hereinafter examined on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-18, 21, & 23 in the reply filed on 02/11/2025 is acknowledged. Claims 1-20 remain pending. Claims 23 is withdrawn. Claims 1-13 are rejected.
Examiners Notes
Applicant is reminded of manner of making amendment in application according to 37 C.F.C. 1.121.(c). The current status of all the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers that includes (withdrawn). See MPEP 714,II,C,(A),
The status of claim 23 in the claims filed on 04/02/2026 should have been corrected to (Withdrawn).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 7 & Claim 18: “the helicoid-shape of the plurality of”
Claim 14: line 1, “wherein”. Appropriate correction is needed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, & 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 1: line 7, “a plurality of markers”. It is unclear if the “plurality of markers” refers to or is separate from the deployed “markers”-line 1 of claim 1. For examination purposes, the Examiner assumes the “plurality of markers” refers to “deploying markers”. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 7: “the tip”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a tip. Accordingly, proper antecedent basis is required.
Claim 18: “the tip”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a tip. Accordingly, proper antecedent basis is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan et al (US20210178139A1).
Claim 1: Ryan discloses, A device (300, ¶¶0037-0038) for deploying markers (322, ¶¶0037-0038), the device comprising:
a deployment catheter (FIG. 3) comprising an elongate body (302) and a cutting tip (¶0038, “Elongate member 302 may be a needle’) at a distal end of the elongate body, (¶¶0037-0038) the deployment catheter defining a first lumen and a second lumen, (¶¶0037-0038, elongate member 302 (i.e., the needle) is defined by a second lumen 310 (first lumen) and a first lumen 308 (second lumen)) the first lumen separate from the second lumen (¶0038, “a first lumen 308 (second lumen) and a second lumen 310 (first lumen) that are parallel to each other and separated by a wall 312.”), the first lumen having a first proximal opening and a distal opening at the cutting tip, (FIG. 3 - second lumen 310 (first lumen), see FIG. 3 highlighted below.) a deployment portion (A-A, FIG. 3) positioned therebetween, (¶¶0038-0039, second lumen 310 (first lumen) features an opening 316 disposed distal end 306 (i.e., tip of the needle). There features a space within this lumen where the pushing element retracts to a loading position represented by reference axis A-A which structurally constitutes as a deployment portion positioned between the proximal end and the distal opening),
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the second lumen having a deployment opening and a second proximal opening, the second lumen shaped and sized to hold a plurality of markers, the deployment opening open to the deployment portion of the first lumen; (¶¶0038-0039, the first lumen 308 (second lumen) includes a loading zone 320 configured to specifically hold a plurality of fiducials 322. This loading zone is open to the adjacent second lumen 310. These 322 are laterally urged from the loading zone 320 toward the second lumen 310 (first lumen), requiring a deployment opening between the two lumens.)
a first push rod (324) positionable within and movable along a length of the first lumen; and (¶¶0038-0039, pushing element 324 is disposed within the second lumen 310 (first lumen). The pushing element 324 is “capable of reciprocal movement to load and eject fiducials 322”-¶0039, which constitutes a push rod movable along the lumen’s length.)
a second push rod (biasing element 318) positionable within and movable along a length of the second lumen independently of the first push rod, the second push rod configured to independently push each one of the plurality of markers from the second lumen into the first lumen via the deployment opening and into a deployed position within the deployment portion, (¶¶0038-0039, Ryan discloses that the second element, (biasing element 318), is a coiled spring, Ryan further states that the biasing element ¶0038-“may be any suitable structure capable of providing a biasing force including, but not limited to, other compressible materials.”. The coil spring designed to exert force constitutes as a second push rod. 318 operates independently of pushing element 314. 318 works in conjunction with a tapered section 314 to push a distal most fiducial 322 out of the loading zone 320 across the gap, and into the second lumen 310 (first lumen). The fiducial is pushed into the deployed position right at the distal end of pushing element 324 when 324 is retracted to its loading position.)
the first push rod configured to push the one of the plurality of markers from the deployed position out of the distal opening at the cutting tip. (¶0039, after the fiducial 322 is loaded into the adjacent lumen, the pushing element 324 is moved distally toward opening 316 to eject a loaded fiducial out of elongate member 302.)
Claim 2: Ryan discloses all the elements above in claim 1, Ryan discloses, wherein: the first push rod is movable between a loading position and a deployment position, (¶¶0038-0039, pushing element 324 is capable of reciprocal movement to load and eject fiducials. The pushing element 324 can be moved distally toward opening 316 to eject a loaded fiducial, which constitutes a deployment position, and can be retracted to a loading position represented by axis A-A.) wherein in the loading position, the first push rod is spaced apart from the deployment portion and the deployment opening, (¶¶0038-0039, pushing element 324 is reacted to is loading position, its distal end is located along axis A-A. By retracting to this axis, 324 vacates the adjacent space within the second lumen 310. This proximal retraction structurally spaces 324 apart from the gap (deployment opening) between the loading zone 320 and the second lumen 310. This spacing is left to be clear so the distalmost fiducial 322 located in the loading zone urges toward the second lumen 310) and in the deployment position, the first push rod extends into the deployment portion to block the deployment opening. (¶¶0038-0039, to eject the fiducial marker 322, the pushing element 324 is moved distally toward opening 316 to eject a loaded fiducial out of elongate member 302. As the pushing element advances distally moving towards the deployment position, its shaft physically extends into and travels through the area where the fiducial was just loaded (deployment portion). Because the shaft of 324 now occupies the second lumen 310 directly adjacent to the loading zone 320, it would be structurally blocking the deployment opening between the two lumens, FIG. 3.)
Claim 3: Ryan discloses all the elements above in claim 1, Ryan discloses, wherein the second lumen includes an elongated section and a ramped portion (tapered section 314) that extends at an angle from the elongated section to intersect the first lumen. (¶¶0038-0039, the first lumen 308 (second lumen) is defined within the elongate member 302 and runs parallel to the adjacent second lumen 310 (first lumen), separated by wall 312. This straight parallel tubular run of the lumen housing element 318 and 322 constitutes as an elongate section. The tapered section 314 extending from an intermediate portion of the elongate member 302 towards an opening at the distal end, this tapered section (ramped portion) extends at an angle because a taper features a sloped or angled surface relative to the straight elongated section from which it originates. Because the sloped surface guides the markers laterally out and across the gap into the adjacent lumen, the tapered section 314 bridges or interacts the space between the first lumen 308 and the second lumen at the loading zone 320.)
Claim 4: Ryan discloses all the elements above in claim 3, Ryan discloses, wherein the intersection of the elongated section and the ramped portion is at the deployment opening. (¶¶0038-0039, the first lumen 308 and the adjacent second lumen 310 are parallel to each other and separated by wall 312. This parallel run of the first lumen 308 forms an elongated section. The tapered section 314 (ramped portion) extends from an intermediate portion of elongate member 302. The location where the straight parallel section of the first lumen 308 transitions into the sloped surface of the tapered section 314 acting as the intersection between the elongated section and the ramped portion. At the loading zone, the wall 312 features a gap or opening to permit the transfer of the markers, which constitutes the deployment opening)
Claim 5: Ryan discloses all the elements above in claim 3, Ryan discloses, wherein the ramped portion (314) and the deployment opening (gap or interface in the separating wall 312 at the loading zone 320) of the second lumen (308) are formed in the elongate body (302). (FIG. 3, these features are structurally under the broadest reasonable interpretation formed within the elongate body.)
Claim 6: Ryan discloses all the elements above in claim 1, Ryan discloses, wherein the first push rod (324) comprises: a body; and a tip positioned distal to the body, wherein the tip is configured to maintain contact with one marker of the plurality of markers when the first push rod pushes the one of the plurality of markers from the deployed position out of the distal opening at the cutting tip (FIG. 3, ¶¶0038-0039).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al (US20210178139A1), as applied to claim 1, in further view of Ramos et al (US 20170202635 A1).
Claim 7: Ryan discloses all the elements above in claim 1, Ryan discloses, wherein: the plurality of markers (322) are shaped, and the tip of the first push rod (324) is configured to engage with the shape of the plurality of markers (FIG. 3, ¶¶0037-0039).
Ryan fails to disclose that the markers are helicoid-shaped.
However, Ramos in the context of tissue site marking for biopsy procedures discloses, markers are helicoid-shaped, ¶0023, ¶0076.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of Ryan to incorporate the helicoid-shaped taught by Ramos because it has been held that “The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.”. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . see MPEP 2144.04 IV B - Changes in Shape. Further, the applicant places no criticality on the shape claimed. Accordingly, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of Ryan such that it is helicoid-shaped as taught by Ramos because in the instant case, the modified would not would not operate differently with claimed helicoid-shaped. One of ordinary skill in the art would be able to obtain such a configuration through routine experimentation.
Ryan fails to disclose: wherein the first push rod is rotatable to rotate the shaped marker of the plurality of markers maintained on the tip.
However, Ramos is relied upon above discloses, wherein the first push rod is rotatable to rotate the shaped marker of the plurality of markers maintained on the tip (¶0076).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of Ryan to incorporate the helicoid-shaped taught by Ramos because it has been held that “The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.”. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . see MPEP 2144.04 IV B - Changes in Shape. Further, the applicant places no criticality on the shape claimed. Accordingly, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of modified Ryan such that it is helicoid-shaped as taught by Ramos because in the instant case, the modified would not would not operate differently with claimed helicoid-shaped. One of ordinary skill in the art would be able to obtain such a configuration through routine experimentation.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the push rod of modified Ryan such that it is rotatable to rotate the shaped marker of the plurality of markers maintained on the tip as taught by Ramos. The motivation to do this yield predictable results such as to firmly fix the helical marker within the tissue with little likelihood of migration, as suggested by Ramos, ¶0076.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al (US20210178139A1), as applied to claim 1, in further view of Field (US 20070038145 A1).
Claim 9: Ryan discloses all the elements above in claim 1, Ryan fails to disclose: further comprising: a first handle operatively coupled to a proximal end of the first push rod; and a second handle operatively coupled to a proximal end of the second push rod, wherein: the first handle is manipulable to move the first push rod along the length of the first lumen, and the second handle is manipulable to move the second push rod along the length of the second lumen.
However, Field in the context of biopsy marker introducer systems discloses, a first handle operatively coupled to a proximal end of the first push rod; and a second handle operatively coupled to a proximal end of the second push rod, wherein: the first handle is manipulable to move the first push rod along the length of the first lumen, and the second handle is manipulable to move the second push rod along the length of the second lumen. (¶0056, ¶0058, ¶0063, ¶0066 ¶¶0068-0069)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the first and second push rods of Ryan to incorporate the teachings of Field. The motivation to do this yield predictable results such as to prevent inaccurate placement of tissue markers that occur when tissue is decompressed, ¶0009 as suggested by Field.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al (US20210178139A1), as applied to claim 1, in further view of Cornell (EP0207726A2).
Claim 10: & Claim 11: Ryan discloses all the elements above in claim 1, Ryan fails to disclose: Claim 10- further comprising: a first set of markings formed in the first push rod, wherein the first set of markings provide a visual representation of a position of the first push rod.
Claim 11- further comprising: a second set of markings formed in the second push rod, wherein the second set of markings provide a visual representation of a position of the second push rod.
However, Cornell the context of biopsy marker introducer systems discloses, a first set of markings formed in the first push rod, wherein the first set of markings provide a visual representation of a position of the first push rod, and a second set of markings formed in the second push rod, wherein the second set of markings provide a visual representation of a position of the second push rod. (page 3 para 2, ‘Graduations may be provided on the actuators to indicate the relative position of the needle and stylet.”)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the first and second push rods of Ryan to include markings as taught by Cornell for the advantage of providing an improved system for determining the relative positions, as suggested by Cornell, pg. 3 ¶2.
Claims 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al (US20210178139A1) in view of Costello et al (US 20150141809 A1).
Claim 12: Ryan discloses, A system (¶Abstract, FIG. 3), the system comprising:
a device (300, ¶¶0037-0038)
the device comprising:
a deployment catheter (FIG. 3) comprising an elongate body (302) and a cutting tip (¶0038, “Elongate member 302 may be a needle’) at a distal end of the elongate body, (¶¶0037-0038) the elongate body defining a first lumen and a second lumen, (¶¶0037-0038, elongate member 302 (i.e., the needle) is defined by a second lumen 310 (first lumen) and a first lumen 308 (second lumen)) the first lumen separate from the second lumen, (¶0038, “a first lumen 308 (second lumen) and a second lumen 310 (first lumen) that are parallel to each other and separated by a wall 312.”) the first lumen having a first proximate opening and a distal opening at the cutting tip, (FIG. 3 - second lumen 310 (first lumen), see FIG. 3 highlighted below.) a deployment portion (A-A, FIG. 3) positioned therebetween, (¶¶0038-0039, second lumen 310 (first lumen) features an opening 316 disposed distal end 306 (i.e., tip of the needle). There features a space within this lumen where the pushing element retracts to a loading position represented by reference axis A-A which structurally constitutes as a deployment portion positioned between the proximal end and the distal opening),
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the second lumen having a deployment opening and a second proximate opening, the second lumen shaped and sized to hold a plurality of markers, the deployment opening open to the deployment portion of the first lumen; (¶¶0038-0039, the first lumen 308 (second lumen) includes a loading zone 320 configured to specifically hold a plurality of fiducials 322. This loading zone is open to the adjacent second lumen 310. These 322 are laterally urged from the loading zone 320 toward the second lumen 310 (first lumen), requiring a deployment opening between the two lumens.)
a first push rod (324) positionable within and movable along a length of the first lumen; and (¶¶0038-0039, pushing element 324 is disposed within the second lumen 310 (first lumen). The pushing element 324 is “capable of reciprocal movement to load and eject fiducials 322”-¶0039, which constitutes a push rod movable along the lumen’s length.)
a second push rod (biasing element 318) positionable within and movable along a length of the second lumen independently of the first push rod, the second push rod configured to independently push each one of the plurality of markers from the second lumen into the first lumen via the deployment opening and into a deployed position within the deployment portion, (¶¶0038-0039, Ryan discloses that the second element, (biasing element 318), is a coiled spring, Ryan further states that the biasing element ¶0038-“may be any suitable structure capable of providing a biasing force including, but not limited to, other compressible materials.”. The coil spring designed to exert force constitutes as a second push rod. 318 operates independently of pushing element 314. 318 works in conjunction with a tapered section 314 to push a distal most fiducial 322 out of the loading zone 320 across the gap, and into the second lumen 310 (first lumen). The fiducial is pushed into the deployed position right at the distal end of pushing element 324 when 324 is retracted to its loading position.)the first push rod configured to push the one of the plurality of markers from the deployed position out of the distal opening at the cutting tip. (¶0039, after the fiducial 322 is loaded into the adjacent lumen, the pushing element 324 is moved distally toward opening 316 to eject a loaded fiducial out of elongate member 302.)
Regarding the limitations of claim 12 – “for performing a biopsy," directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the invention of Ryan is capable of performing the functions as set forth by applicant, see MPEP 2114.
Note, Ryan disclose, ¶0066 “the apparatuses and methods described herein may be used through any natural body lumen or tract, including those accessed orally, vaginally, rectally, nasally, urethrally, or through incisions in any suitable tissue.”
Ryan fails to disclose: the system comprising:
a bronchoscope with a channel formed therein;
the device configured to be inserted into the channel of the bronchoscope,
However, Costello in the context of navigation of a biopsy tool using a bronchoscope discloses, a bronchoscope with a channel formed therein; a device configured to be inserted into the channel of the bronchoscope, (¶¶0044-0047)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of Ryan to be configured to incorporate the teachings of Costello bronchoscope such that the device be inserted into the channel of the bronchoscope as taught by Costello. The motivation to do this yield predictable results such as to navigate through a patient’s airways to a target location to obtain a tissue sample for diagnostic testing, as suggested by Costello, ¶0035.
Claim 13: Ryan as modified discloses all the elements above in claim 12, Ryan discloses, wherein: the first push rod is movable between a loading position and a deployment position, (¶¶0038-0039, pushing element 324 is capable of reciprocal movement to load and eject fiducials. The pushing element 324 can be moved distally toward opening 316 to eject a loaded fiducial, which constitutes a deployment position, and can be retracted to a loading position represented by axis A-A.) wherein in the loading position, the first push rod is spaced apart from the deployment portion and the deployment opening, (¶¶0038-0039, pushing element 324 is reacted to is loading position, its distal end is located along axis A-A. By retracting to this axis, 324 vacates the adjacent space within the second lumen 310. This proximal retraction structurally spaces 324 apart from the gap (deployment opening) between the loading zone 320 and the second lumen 310. This spacing is left to be clear so the distalmost fiducial 322 located in the loading zone urges toward the second lumen 310) and in the deployment position, the first push rod extends into the deployment portion to close off the deployment opening. (¶¶0038-0039, to eject the fiducial marker 322, the pushing element 324 is moved distally toward opening 316 to eject a loaded fiducial out of elongate member 302. As the pushing element advances distally moving towards the deployment position, its shaft physically extends into and travels through the area where the fiducial was just loaded (deployment portion). Because the shaft of 324 now occupies the second lumen 310 directly adjacent to the loading zone 320, it would be structurally blocking the deployment opening between the two lumens, FIG. 3.)
Claim 14: Ryan as modified discloses all the elements above in claim 12, Ryan discloses, in which the second lumen includes an elongated section and a ramped portion (tapered section 314) that extends obliquely from the elongated section to intersect the first lumen. (¶¶0038-0039, the first lumen 308 (second lumen) is defined within the elongate member 302 and runs parallel to the adjacent second lumen 310 (first lumen), separated by wall 312. This straight parallel tubular run of the lumen housing element 318 and 322 constitutes as an elongate section. The tapered section 314 extending from an intermediate portion of the elongate member 302 towards an opening at the distal end, this tapered section (ramped portion) extends at an angle because a taper features a sloped or angled surface relative to the straight elongated section from which it originates. Because the sloped surface guides the markers laterally out and across the gap into the adjacent lumen, the tapered section 314 bridges or interacts the space between the first lumen 308 and the second lumen at the loading zone 320.)
Claim 15: Ryan as modified discloses all the elements above in claim 14, Ryan discloses, wherein the intersection of the elongated section and the ramped portion is at the deployment opening. (¶¶0038-0039, the first lumen 308 and the adjacent second lumen 310 are parallel to each other and separated by wall 312. This parallel run of the first lumen 308 forms an elongated section. The tapered section 314 (ramped portion) extends from an intermediate portion of elongate member 302. The location where the straight parallel section of the first lumen 308 transitions into the sloped surface of the tapered section 314 acting as the intersection between the elongated section and the ramped portion. At the loading zone, the wall 312 features a gap or opening to permit the transfer of the markers, which constitutes the deployment opening)
Claim 16: Ryan as modified discloses all the elements above in claim 14, Ryan discloses, wherein the ramped portion (314) and the deployment opening (gap or interface in the separating wall 312 at the loading zone 320) of the second lumen (308) are formed in the elongate body (302). (FIG. 3, these features are structurally under the broadest reasonable interpretation formed within the elongate body.)
Claim 17: Ryan as modified discloses all the elements above in claim 12, Ryan discloses, wherein the first push rod (324) includes a body and a tip positioned distal to the elongate body, the tip being configured to maintain contact with one marker of the plurality of markers when the first push rod pushes the one of the plurality of markers from the deployed position out of the distal opening at the cutting tip (FIG. 3, ¶¶0038-0039).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al (US20210178139A1) in view of Costello et al (US 20150141809 A1), as applied to claim 12, in further view of Ramos et al (US 20170202635 A1).
Claim 18: Ryan as modified discloses all the elements above in claim 12, Ryan discloses, wherein: the plurality of markers (322) are shaped, and the tip of the first push rod (324) is configured to engage with the shape of the plurality of markers (FIG. 3, ¶¶0037-0039).
Ryan fails to disclose: wherein: the plurality of markers are helicoid-shaped, the tip of the first push rod is configured to engage with helicoid-shape of the plurality of markers, and the first push rod is rotatable to rotate the helicoid-shaped marker of the plurality of markers maintained on the tip.
However, Ramos in the context of tissue site marking for biopsy procedures discloses, markers are helicoid-shaped, ¶0023, ¶0076.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of Ryan to incorporate the helicoid-shaped taught by Ramos because it has been held that “The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.”. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . see MPEP 2144.04 IV B - Changes in Shape. Further, the applicant places no criticality on the shape claimed. Accordingly, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of modified Ryan such that it is helicoid-shaped as taught by Ramos because in the instant case, the modified would not would not operate differently with claimed helicoid-shaped. One of ordinary skill in the art would be able to obtain such a configuration through routine experimentation.
Ryan fails to disclose: the tip of the first push rod is configured to engage with helicoid-shape of the plurality of markers, and the first push rod is rotatable to rotate the helicoid-shaped marker of the plurality of markers maintained on the tip.
However, Ramos is relied upon above discloses, the tip of the first push rod is configured to engage with helicoid-shape of the plurality of markers, and the first push rod is rotatable to rotate the helicoid-shaped marker of the plurality of markers maintained on the tip. (¶0076).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of Ryan to incorporate the helicoid-shaped taught by Ramos because it has been held that “The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.”. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . see MPEP 2144.04 IV B - Changes in Shape. Further, the applicant places no criticality on the shape claimed. Accordingly, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the shape of the markers of modified Ryan such that it is helicoid-shaped as taught by Ramos because in the instant case, the modified would not would not operate differently with claimed helicoid-shaped. One of ordinary skill in the art would be able to obtain such a configuration through routine experimentation.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the tip of the push rod of modified Ryan such that it is configured to engage with helicoid-shape of the plurality of markers, and the first push rod is rotatable to rotate the helicoid-shaped marker of the plurality of markers maintained on the tip as taught by Ramos. The motivation to do this yield predictable results such as to firmly fix the helical marker within the tissue with little likelihood of migration, as suggested by Ramos, ¶0076.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al (US20210178139A1) in view of Costello et al (US 20150141809 A1), as applied to claim 12, in further view of Cornell (EP0207726A2).
Claim 21: Ryan as modified discloses all the elements above in claim 12, Ryan fails to disclose: further comprising: a first set of markings formed in the first push rod, the first set of markings provide a visual representation of a position of the first push rod, and a second set of markings formed in the second push rod, the second set of markings provide a visual representation of a position of the second push rod.
However, Cornell the context of biopsy marker introducer systems discloses, further comprising: a first set of markings formed in the first push rod, the first set of markings provide a visual representation of a position of the first push rod, and a second set of markings formed in the second push rod, the second set of markings provide a visual representation of a position of the second push rod. (page 3 para 2, ‘Graduations may be provided on the actuators to indicate the relative position of the needle and stylet.”)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the first and second push rods of modified Ryan to include markings as taught by Cornell for the advantage of providing an improved system for determining the relative positions, as suggested by Cornell, pg. 3 ¶2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burbank et al (US 20100298698 A1), Burbank in the context of tissue site marking for biopsy procedures discloses, markers are helicoid-shaped, ¶0037, ¶0061, FIG. 4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
